Japanese drugmaker Astellas and FibroGen reported that a US patient died of liver failure after taking their experimental anemia medicine known as FG-2216.
FibroGen, based in San Francisco, reported the fatality to the FDA and will discuss the cause of death and future plans for the drug with the FDA, Astellas said in a statement on its Web site. Both companies are analyzing information on the case, which involved a 76-year-old patient taking 10 other medications, according to Astellas.
FG-2216 is in Phase II testing and aims to help patients with chronic kidney disease and cancer increase levels of erythropoietin that stimulates production of red-blood cells.
FG-2216 is an oral treatment being developed as an alternative to Amgen’s Epogen and Aranesp and Johnson & Johnson’s Procrit, injectables that have been linked to deadly side effects, including strokes and heart attacks, in patients with chronic kidney failure.